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Last Updated: May 20, 2024

CICLOPIROX - Generic Drug Details


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What are the generic sources for ciclopirox and what is the scope of patent protection?

Ciclopirox is the generic ingredient in three branded drugs marketed by Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Medimetriks Pharms, Alvogen, Glenmark Pharms Inc, Padagis Us, Actavis Mid Atlantic, Encube, Bausch, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, Taro Pharm Inds, Teva Pharms, and Valeant Bermuda, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for ciclopirox. Sixteen suppliers are listed for this compound.

Drug Prices for CICLOPIROX

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Drug Sales Revenue Trends for CICLOPIROX

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Recent Clinical Trials for CICLOPIROX

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SponsorPhase
Universidad Complutense de MadridPhase 4
Atlas Molecular PharmaPhase 1
BritaMed, Inc.N/A

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Pharmacology for CICLOPIROX
Paragraph IV (Patent) Challenges for CICLOPIROX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CICLOPIROX Gel ciclopirox 0.77% 020519 1 2006-05-10

US Patents and Regulatory Information for CICLOPIROX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Israel CICLOPIROX ciclopirox SUSPENSION;TOPICAL 077676-001 Dec 15, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms CICLOPIROX ciclopirox SOLUTION;TOPICAL 078079-001 Sep 18, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms CICLOPIROX ciclopirox CREAM;TOPICAL 090273-001 Nov 10, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CICLOPIROX ciclopirox SHAMPOO;TOPICAL 078594-001 Feb 16, 2010 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Encube CICLOPIROX ciclopirox SOLUTION;TOPICAL 077687-001 Sep 18, 2007 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CICLOPIROX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimetriks Pharms LOPROX ciclopirox SUSPENSION;TOPICAL 019824-001 Dec 30, 1988 ⤷  Try a Trial ⤷  Try a Trial
Alvogen CICLOPIROX ciclopirox GEL;TOPICAL 020519-001 Jul 21, 1997 ⤷  Try a Trial ⤷  Try a Trial
Medimetriks Pharms LOPROX ciclopirox CREAM;TOPICAL 018748-001 Dec 30, 1982 ⤷  Try a Trial ⤷  Try a Trial
Valeant Bermuda PENLAC ciclopirox SOLUTION;TOPICAL 021022-001 Dec 17, 1999 ⤷  Try a Trial ⤷  Try a Trial
Bausch LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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